busulfan

Generic: busulfan

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name busulfan
Generic Name busulfan
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

busulfan 6 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-395
Product ID 55150-395_06883ac0-4b2a-4f26-89bf-512d37b9ba7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215102
Listing Expiration 2026-12-31
Marketing Start 2024-06-25

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150395
Hyphenated Format 55150-395

Supplemental Identifiers

RxCUI
253113
UPC
0355150395019
UNII
G1LN9045DK
NUI
N0000000236 N0000175558

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name busulfan (source: ndc)
Generic Name busulfan (source: ndc)
Application Number ANDA215102 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/mL
source: ndc
Packaging
  • 8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01)
source: ndc

Packages (1)

55150-395-08 8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01)

Ingredients (1)

busulfan (6 mg/mL)

Linked Drug Pages (1)

Busulfan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "06883ac0-4b2a-4f26-89bf-512d37b9ba7f", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0355150395019"], "unii": ["G1LN9045DK"], "rxcui": ["253113"], "spl_set_id": ["06883ac0-4b2a-4f26-89bf-512d37b9ba7f"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08)  / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01)", "package_ndc": "55150-395-08", "marketing_start_date": "20240625"}], "brand_name": "Busulfan", "product_id": "55150-395_06883ac0-4b2a-4f26-89bf-512d37b9ba7f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "55150-395", "generic_name": "Busulfan", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Busulfan", "active_ingredients": [{"name": "BUSULFAN", "strength": "6 mg/mL"}], "application_number": "ANDA215102", "marketing_category": "ANDA", "marketing_start_date": "20240625", "listing_expiration_date": "20261231"}